Gert Moelgaard about Trends in the Pharmaceutical Industry Why Specialty Medicine Becomes a Challenge to Manufacturing

Editor: Anke Geipel-Kern

After the traditional blockbuster era the new blockbusters are specialty medicines — This may change the manufacturing strategy for many pharmaceutical companies and it means new opportunities and challenges for pharmaceutical manufacturing. But today’s technology and equipment require rethinking of the industry to meet the demands of the “new pharma reality”. Who is going to make the pace?

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Gert Moelgaard: “Pharmaceutical equipment is in general not made to be flexible. Most of the traditional solutions are not quick to change and clean between products.”
Gert Moelgaard: “Pharmaceutical equipment is in general not made to be flexible. Most of the traditional solutions are not quick to change and clean between products.”
(Bild: NNE Pharmaplan)

Speciality medicine has become a major growth driver in the pharmaceutical industry. It used to be a small niche area, at least from a manufacturing volume perspective, but it has been driving big company investments in R&D as well as mergers and acquisitions for some time and recently it has become a driver for some of the largest company takeovers in many years.

New Treatments Make Patients Life More Easy

From a manufacturing perspective, it is also a special area because the products are very different from the former blockbuster products that were produced in high volumes and often in dedicated facilities for each blockbuster product. The old blockbusters required large capacity to meet the international demand but this is not the case for the new blockbusters because they address smaller and specialised markets. The new, innovative pharmaceutical products are generally more expensive than a blockbuster product was a decade ago despite the pricing of innovative drugs has become an area of heated political debate and attention.

Some of the most costly diseases in the Western world have been met by medicines that make a big difference in the life of the patients. Some of these are small indications but not all. Take for example the treatments for the rheumatoid arthritis where new treatments have improved life for thousands of patients throughout the industrial world and now spread into emerging markets as well. Improvement of life includes ability to work and live normally with no or few long-term effects that were unthinkable only 10 years ago. Same for several cancer types, for sclerosis, hepatitis C and many more types of chronic diseases — or previously chronic diseases.

But Causes a Trend Towards Smaller Products

This is probably part of a pharmaceutical mega­trend towards smaller products (from a volume perspective, not a value perspective) — and a strong need for flexibility. Unlike the old blockbuster plants the pharmaceutical facilities of the future will not be dedicated. They will be flexible. They will have to be multiproduct capable and flexible. Some of these new and smaller products will be made by contract manufacturers who always needed the multiproduct capabilities but in future CMOs will need more flexibility and agility to meet the market demands.

Pharmaceutical equipment is in general not made to be flexible. Most of the traditional solutions are not quick to change and clean between products.

Change Over Efficiency is a Necessity

There has been more focus on operational efficiency than on changeover efficiency. Like in the automotive industry 25 years ago. Car models used to be made in dedicated facilities but car manufacturers shifted to flexible manufacturing many years ago, using lots of robots and modular design platform solutions that makes a modern and agile manufacturing environment.

The pharmaceutical industry has very few robots, mainly in the packaging and warehouse facilities. This will have to change because in other industries flexibility goes hand in hand with robots but also because pharmaceuticals should preferably be manufactured with few or no operators in the manufacturing areas around the critical processes, especially in aseptic processing. Besides facilities with high potent ingredients and drugs have a very complicated and expensive challenge to ensure the containment and EHS requirements for manual operations.

And a New Paradigm is Needed

There is a need for a new manufacturing paradigm to meet the future needs of the pharmaceutical industry as specialty medicine continues to grow — and new, small products (from a volume perspective) are needed within immunotherapy, orphan drugs and even personalised medicine. The industry and its equipment manufacturers will have to start moving and dare being first movers in these new areas. We need some innovative partnerships and some first movers which dare to demonstrate the new flexible and agile solutions with a high effectiveness.

Because we will need these agile, flexible and effective solutions to meet the demands for the pharmaceutical facilities of the future...